CN116075329A - Valve assembly for a drug delivery device - Google Patents

Abstract

A valve assembly for a drug delivery device comprising: a valve housing; a sleeve having a first end and a second end positioned opposite the first end; a valve housing connected to the valve housing and defining an interior space; a valve sleeve defining a sleeve space, wherein the valve sleeve is configured to move from a pre-use position, in which the first end of the sleeve is received within the sleeve space, to a use position, in which the first end of the sleeve extends outside of the valve sleeve and the sleeve space; and a piercing member having a body with a piercing tip. The body of the piercing member has a first end and a second end positioned opposite the first end, wherein the piercing member engages the valve sleeve.

Description

Valve assembly for a drug delivery device

Cross Reference to Related Applications

The present application claims priority from U.S. provisional application Ser. No. 63/054,850, filed 7/22/2020, the entire disclosure of which is incorporated herein by reference.

Background

Technical Field

The present disclosure relates generally to drug delivery devices and, more particularly, to a valve assembly for a drug delivery device.

Description of the Related Art

Various types of automatic injection devices or drug delivery devices have been developed to allow drug solutions and other liquid therapeutic formulations to be administered or self-injected by untrained personnel. Typically, these devices include a reservoir pre-filled with a liquid therapeutic agent, and some type of automatic needle injection mechanism that can be triggered by the user. While the volume of fluid or drug to be administered is typically below a certain volume (e.g., 1 mL), an auto-injector is typically used, which typically has an injection time of about 10 seconds to 15 seconds. When the volume of fluid or drug to be administered exceeds 1mL, the injection time typically becomes longer, making it difficult for the patient to maintain contact between the device and the target area of the patient's skin. Furthermore, as the volume of drug to be administered becomes larger, it becomes desirable to extend the period of injection. The traditional method of slowly injecting a drug into a patient is to initiate an Intravenous (IV) injection and slowly inject the drug into the patient. Such procedures are typically performed at a hospital or clinic.

Some devices allow self-injection in a home environment and are capable of gradually injecting a liquid therapeutic formulation into the skin of a patient. In some cases, these devices are small enough (whether in height or overall size) to allow the patient to "wear" the liquid therapeutic formulation when it is infused into the patient. These devices typically include a pump or other type of discharge mechanism to force the liquid therapeutic formulation out of the reservoir and into the injection needle. Such devices also typically include a valve or flow control mechanism for initiating flow of the liquid therapeutic formulation at the appropriate time, and a trigger mechanism for initiating injection.

Disclosure of Invention

In one aspect or embodiment, a valve assembly for a drug delivery device comprises: a valve housing having a first side and a second side positioned opposite the first side; a sleeve having a first end and a second end positioned opposite the first end, the sleeve defining a central passage; a valve housing coupled to the valve housing and defining an interior space, wherein the valve housing is configured to move from a pre-use position, in which the first end of the sleeve is received within the interior space, to a use position, in which the first end of the sleeve extends outside of the valve housing and the interior space; a valve sleeve defining a sleeve space, wherein the valve sleeve is configured to move from a pre-use position, in which the first end of the sleeve is received within the sleeve space, to a use position, in which the first end of the sleeve extends outside of the valve sleeve and the sleeve space; and a piercing member having a body with a piercing tip. The body of the piercing member has a first end and a second end positioned opposite the first end, wherein the piercing member engages the valve sleeve.

The piercing member may be completely spaced apart from the valve housing. The second end of the body of the piercing member engages the valve sleeve. The second end of the body of the piercing member may be received by a recessed area defined by the valve sleeve.

The valve sleeve may include a cylindrical first portion having a convex tip, a second portion extending from the first portion, and a frustoconical third portion extending from the second portion. The second end of the body of the piercing member may be received by a recessed area defined by the second portion of the valve sleeve. The cylindrical first portion of the valve sleeve may be positioned between the first end and the second end of the body of the piercing member. The body of the piercing member may be cylindrical.

The body of the piercing member may define a central passage, wherein the central passage receives a portion of the valve sleeve. The valve sleeve may be formed of an elastomeric material. The second portion of the valve sleeve may comprise a frustoconical section and a cylindrical section. The third portion of the valve sleeve may include at least one recess configured to facilitate telescoping and deforming of the valve sleeve. The valve housing may be formed of an elastic material. The piercing member may be formed of metal.

In another aspect or embodiment, a drug delivery device comprises: a housing; a cartridge received within the housing, wherein the cartridge is configured to receive a medicament; a drive assembly received within the housing and configured to engage the cartridge and dispense a medicament from the cartridge; a needle actuator assembly received within the housing, wherein the needle actuator assembly includes a patient needle configured to pierce the skin of a patient; and a valve assembly as described in any of the aspects or embodiments discussed above.

Drawings

The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and the disclosure itself will be better understood by reference to the following description of embodiments of the disclosure taken in conjunction with the accompanying drawings, wherein:

fig. 1 is a perspective view of a drug delivery system according to an aspect or embodiment of the present application.

Fig. 2 is a perspective cross-sectional view of the drug delivery system of fig. 1.

Fig. 3 is a front cross-sectional view of the drug delivery system of fig. 1.

Fig. 4 is a top view of the drug delivery system of fig. 1, showing the top portion of the housing removed and the drug delivery system in a pre-use position.

Fig. 5 is a top cross-sectional view of the drug delivery system of fig. 1, showing the drug delivery system in a pre-use position.

Fig. 6 is a front cross-sectional view of the drug delivery system of fig. 1, showing the drug delivery system in a pre-use position.

Fig. 7 is a top view of the drug delivery system of fig. 1, shown with a top portion of the housing removed and the drug delivery system in an initial actuated position.

Fig. 8 is a top cross-sectional view of the drug delivery system of fig. 1, showing the drug delivery system in an initial actuated position.

Fig. 9 is a front cross-sectional view of the drug delivery system of fig. 1, showing the drug delivery system in an initial actuated position.

Fig. 10 is a top view of the drug delivery system of fig. 1, shown with a top portion of the housing removed and the drug delivery system in a use position.

Fig. 11 is a top cross-sectional view of the drug delivery system of fig. 1, showing the drug delivery system in a use position.

Fig. 12 is a front cross-sectional view of the drug delivery system of fig. 1, showing the drug delivery system in a use position.

Fig. 13 is a top view of the drug delivery system of fig. 1, showing the top portion of the housing removed and the drug delivery system in a post-use position.

Fig. 14 is a top cross-sectional view of the drug delivery system of fig. 1, showing the drug delivery system in a post-use position.

Fig. 15A is a front cross-sectional view of the drug delivery system of fig. 1, showing the drug delivery system in a post-use position.

Fig. 15B is a front cross-sectional view of the drug delivery system of fig. 1, showing the pad and drug delivery system in a pre-use position.

Fig. 15C is a perspective cross-sectional view of the drug delivery system of fig. 1, showing the pad and drug delivery system in a pre-use position.

Fig. 15D is a perspective cross-sectional view of the drug delivery system of fig. 1, showing the pad and drug delivery system in a pre-use position.

Fig. 16 is a partial cross-sectional view of the drug delivery system of fig. 1, showing a valve assembly.

Fig. 17 is a cross-sectional view of a valve assembly of the drug delivery system of fig. 1.

Fig. 18 is a perspective view of a valve sleeve of the valve assembly of the drug delivery system of fig. 1.

Fig. 19 is a perspective view of a piercing member of the valve assembly of the drug delivery system of fig. 1.

Detailed Description

The following description is presented to enable one of ordinary skill in the art to make and use the described embodiments that are intended to practice the invention. Various modifications, equivalents, changes, and substitutions will, however, be apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the present invention.

For purposes of the following description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "transverse," "longitudinal," and derivatives thereof shall relate to the invention as oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the devices shown in the attached drawings and described in the following specification are simply exemplary embodiments of the invention. Thus, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.

Referring to fig. 1-16, drug delivery system 10 includes drive assembly 12, container 14, valve assembly 16, and needle actuator assembly 18. Drive assembly 12, container 14, valve assembly 16, and needle actuator assembly 18 are positioned at least partially within housing 20. The housing 20 includes a top portion 22 and a bottom portion 24, although other suitable configurations for the housing 20 may be used. In one aspect, the drug delivery system 10 is an injector device configured to be worn or secured to a user and deliver a predetermined dose of medicament provided within the container 14 via injection into the user. System 10 may be used to deliver a "bolus" in which the agent is delivered over a set period of time. The agent may be delivered over a period of up to 45 minutes, although other suitable injection amounts and durations may be used. Bolus administration or delivery may be performed with or without specific rate control. The system 10 may deliver a medicament at a fixed pressure to a user at a variable rate. The general operation of the system 10 is described below with reference to fig. 1-16.

Referring again to fig. 1-16, the system 10 is configured to be operated by a user engaging the actuation button 26, which causes the needle 28 of the needle assembly 18 to pierce the user's skin, actuating the drive assembly 12 to place the needle 28 in fluid communication with the container 14 and expel fluid or medicament from the container 14, and withdrawing the needle 28 after injection of the medicament is complete. The general operation of the drug delivery system is shown and described in International publication No. 2013/155153 and International publication No. 2014/179774, the entire contents of which are incorporated herein by reference. The operation of system 10 is also shown and described in U.S. publication No. 2017/0354788, the entire contents of which are incorporated herein by reference. The housing 20 of the system 10 includes an indicator window 30 for viewing an indicator device 32 and a container window 31 for viewing the container 14, the indicator device 32 being configured to provide an indication to a user regarding the condition of the system 10. The indicator window 30 may be a magnifying glass for providing a clear view of the indicator device 32. Indicator device 32 moves with needle actuator assembly 18 during use of system 10 to indicate a pre-use condition, a use condition, and a post-use condition of system 10. The indicator device 32 provides visual indicia regarding the condition, although other suitable indicia, such as audible or tactile indicia, may be provided instead of or in addition to the indicia.

Referring to fig. 4-6, during a pre-use position of system 10, container 14 is spaced apart from drive assembly 12 and valve assembly 16, and needle 28 is in a retracted position. During initial actuation of the system 10, as shown in fig. 7-9, the drive assembly 12 engages the container 14 to move the container 14 toward the valve assembly 16, the valve assembly 16 being configured to pierce the closure 36 of the container 14 and place the medicament within the container 14 in fluid communication with the needle 28 via a tube (not shown) or other suitable configuration. The drive assembly 12 is configured to engage the stopper 34 of the container 14, thus initially moving the entire container 14 into engagement with the valve assembly 16 due to incompressibility of the fluid or medicament within the container 14. Initial actuation of the system 10 is caused by the user engaging the actuation button 26, which releases the needle actuator assembly 18 and the drive assembly 12, as discussed in more detail below. During initial actuation, needle 28 is still in the retracted position and will be moved to the extended position for injection by a user of system 10.

During the use position of the system 10, as shown in fig. 10-12, the needle 28 is in an extended position, at least partially outside of the housing 20, wherein the drive assembly 12 moves the stopper 34 within the container 14 to deliver medicament from the container 14 through the needle 28 to a user. In the use position, valve assembly 16 has pierced closure 36 of container 14 to place container 14 in fluid communication with needle 28, which also allows drive assembly 12 to move stopper 34 relative to container 14 (as fluid can be dispensed from container 14). In the post-use position of the system 10 shown in fig. 13-15, the needle 28 is in a retracted position and engages the pad 38 to seal the needle 28 and prevent any residual flow of fluid or medicament from the container 14.

Referring to fig. 16-19, as described above, valve assembly 16 operates to facilitate fluid communication between container 14 and needle actuator assembly 18. Valve assembly 16 includes valve housing 52, sleeve 54, piercing member 56, and valve cover 58. The valve assembly 16 also includes a valve sleeve 60. The valve housing 52 has a first side 62 and a second side 64 positioned opposite the first side 62. The valve housing 52 may be integrally formed with the housing 20 of the system 10 or may be formed as a separate component. The sleeve 54 has a first end 66 and a second end 68 positioned opposite the first end 66. The sleeve 54 defines a central passage 70. The first end 66 of the cannula 54 is sharpened and configured to pierce the septum of the container 14. The second end 68 of the sleeve 54 is received by the valve housing 52 and secured to the valve housing 52. The valve housing 52 is in fluid communication with the needle actuator assembly 18 via a conduit (not shown) to form a fluid flow path from the sleeve 54 to the needle actuator assembly 18.

Referring again to fig. 16-19, piercing member 56 includes a body 72 having a piercing tip 74 extending from body 72. The body 72 of the piercing member 56 has a first end 76 and a second end 78 positioned opposite the first end 76. A piercing tip 74 extends from a first end 76 of the body 72. Piercing member 56 engages valve sleeve 60. The piercing member 56 is fully spaced from the valve housing 58. In one aspect or embodiment, the piercing member 56 is not in direct contact with the valve housing 58 or in indirect contact with the valve housing 58. Second end 78 of body 72 of piercing member 56 engages valve sleeve 60. In one aspect or embodiment, the second end 78 of the body 72 is received by a recessed area 80 defined by the valve sleeve 60. The body 72 of the piercing member 56 is cylindrical, although other suitable shapes and configurations may be used. The body 72 of the piercing member 56 defines a central passage 82 that receives a portion of the valve sleeve 60. In one aspect or embodiment, the piercing member 56 is snugly positioned on the valve sleeve 60 with the piercing member 56 contacting the valve sleeve 60 from a first end 76 of the body 72 to a second end 78 of the body 72. Piercing member 56 is formed of metal, although other suitable materials may be utilized. Piercing member 56 may be manufactured using stamping, rolling, and/or forming processes.

The valve housing 58 is connected to the valve housing 52 and defines an interior space 84. The valve cover 58 may be formed of an elastomeric material, although other suitable materials or combinations of materials may be used. The valve housing 58 is configured to move from a pre-use position, in which the first end 66 of the cannula 54 and the piercing tip 74 of the piercing member 56 are received within the interior space 84, to a use position, in which the piercing tip 74 of the piercing member 56 and the first end 66 of the cannula 54 extend outside of the valve housing 58 and the interior space 84. The pre-use position of the valve cover 58 and valve assembly 16 is shown in fig. 17. The use position of the valve cover 58 and valve assembly 16 is shown in fig. 16. In the use position, the piercing tip 74 pierces the valve closure 58 and a foil seal (not shown) on the container 14, and the sleeve 54 pierces the septum of the container 14 to provide fluid communication with the interior of the container 14 and the piercing member 56 moving toward the valve housing 52.

Referring to fig. 16-18, the valve sleeve 60 is positioned within an interior space 84 defined by the valve cover 58. Valve sleeve 60 defines a sleeve space 86 and is configured to move from a pre-use position, in which first end 66 of sleeve 54 is received within sleeve space 86, to a use position, in which first end 66 of sleeve 54 extends outside of valve sleeve 60 and sleeve space 86. The valve sleeve 60 may be formed of an elastomeric material (e.g., a rubber material), although other suitable materials or combinations of materials may be used. The valve sleeve 60 includes a cylindrical first portion 88 having a convex tip 90, a second portion 92 extending from the first portion 88, and a frustoconical third portion 94 extending from the second portion 92. The second portion 92 is a combination of frustoconical and cylindrical. The third portion 94 of the valve sleeve 60 may include one or more recesses 96 to facilitate telescoping and deformation of the valve sleeve 60. When valve assembly 16 is engaged with container 14, valve sleeve 60 will retract as first end 66 of sleeve 54 extends through valve sleeve 60.

The valve sleeve 60 is configured to ensure that the sleeve 54 and flow path of the system 10 are protected from contamination during operation of the system 10. During operation of the system 10, as described above, the container 14 is moved into engagement with the valve cover 58 to collapse the valve cover 58, and the piercing tip 74 of the piercing member 56 pierces the foil seal of the container 14 and the valve cover 58 to form a corresponding chad or flap (not shown). The valve sleeve 60 prevents any contaminants present on the container 14 and valve cover 58 from being discharged or thrown from the container 14 or valve cover 58 onto the sleeve 54 or into the sleeve 54. The valve sleeve 60 also shields the cannula 54 from contact with the chad or flap formed by the piercing member 76 and minimizes the surface area of the closure 36 of the container 14 through which the cannula 54 must pass. The valve sleeve 60 is also configured to: when the valve cover 58 is compressed and then pierced by the piercing member 76, contamination caused by decompression of the valve cover 58 is prevented by preventing entrained contaminants from adhering to the outer and inner surfaces of the sleeve 54.

In one aspect or embodiment, the second end 78 of the body 72 of the piercing member 56 can be flared to allow the piercing member 56 to more easily slide over the cylindrical first portion 88 of the valve sleeve 60.

In one aspect or embodiment, the thickness of the valve sleeve 60 and the angle of the cylindrical first portion 88, the angle of the second portion 92, and the angle of the third portion 94 may be varied to optimize the force required to move the valve sleeve from the pre-use position to the use position. As described above, the valve sleeve 60 may be configured to completely pierce the valve cover 58 prior to telescoping or moving the valve sleeve 60 from the pre-use position to the use position.

Referring again to fig. 17, the second end 78 of the body 72 of the piercing member 56 is received in the recessed area 80 defined by the second portion 92 of the valve sleeve 60. The cylindrical first portion 88 of the valve sleeve 60 is positioned between the first end 76 and the second end 78 of the body 72 of the piercing member 56.

Elements of one disclosed aspect may be combined with elements of one or more other disclosed aspects to form various combinations, all of which are considered to be within the scope of the invention.

While this disclosure has been described as having an exemplary design, the present disclosure may be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the disclosure using its general principles. Furthermore, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this disclosure pertains and which fall within the limits of the appended claims.

Claims (15)

1. A valve assembly for a drug delivery device, the valve assembly comprising:

a valve housing having a first side and a second side positioned opposite the first side;

a sleeve having a first end and a second end positioned opposite the first end, the sleeve defining a central passage;

a valve housing connected to the valve housing and defining an interior space, the valve housing configured to move from a pre-use position, in which the first end of the sleeve is received within the interior space, to a use position, in which the first end of the sleeve extends outside of the valve housing and the interior space;

a valve sleeve defining a sleeve space, the valve sleeve configured to move from a pre-use position, in which the first end of the sleeve is received within the sleeve space, to a use position, in which the first end of the sleeve extends outside of the valve sleeve and the sleeve space; and

a piercing member having a body with a piercing tip, the body of the piercing member having a first end and a second end positioned opposite the first end of the body, the piercing member engaging the valve sleeve.

2. The valve assembly of claim 1, wherein the piercing member is fully spaced apart from the valve housing.

3. The valve assembly of claim 1, wherein the second end of the body of the piercing member engages the valve sleeve.

4. The valve assembly of claim 3, wherein the second end of the body of the piercing member is received by a recessed area defined by the valve sleeve.

5. The valve assembly of claim 1, wherein the valve sleeve comprises a cylindrical first portion having a convex tip, a second portion extending from the first portion, and a frustoconical third portion extending from the second portion.

6. The valve assembly of claim 5, wherein the second end of the body of the piercing member is received by a recessed area defined by the second portion of the valve sleeve.

7. The valve assembly of claim 5, wherein the cylindrical first portion of the valve sleeve is positioned between the first and second ends of the body of the piercing member.

8. The valve assembly of claim 5, wherein the second portion of the valve sleeve comprises a frustoconical section and a cylindrical section.

9. The valve assembly of claim 5, wherein the third portion of the valve sleeve comprises at least one recess configured to facilitate telescoping and deforming of the valve sleeve.

10. The valve assembly of claim 1, wherein the body of the piercing member is cylindrical.

11. The valve assembly of claim 1, wherein the body of the piercing member defines a central passage that receives a portion of the valve sleeve.

12. The valve assembly of claim 1, wherein the valve sleeve comprises an elastomeric material.

13. The valve assembly of claim 1, wherein the valve housing comprises an elastomeric material.

14. The valve assembly of claim 1, wherein the piercing member comprises metal.

15. A drug delivery device, the drug delivery device comprising:

a housing;

a cartridge received within the housing, the cartridge configured to receive a medicament;

a drive assembly received within the housing and configured to engage the cartridge and dispense a medicament from the cartridge;

a needle actuator assembly received within the housing, the needle actuator assembly comprising a patient needle configured to pierce the skin of a patient; and

a valve assembly, the valve assembly comprising:

a valve housing having a first side and a second side positioned opposite the first side;

a sleeve having a first end and a second end positioned opposite the first end, the sleeve defining a central passage,

a valve housing connected to the valve housing and defining an interior space, the valve housing being configured to move from a pre-use position, in which the first end of the sleeve is received within the interior space, to a use position, in which the first end of the sleeve extends outside of the valve housing and the interior space,

a valve sleeve defining a sleeve space, the valve sleeve configured to move from a pre-use position, in which the first end of the sleeve is received within the sleeve space, to a use position, in which the first end of the sleeve extends outside of the valve sleeve and the sleeve space, and

a piercing member having a body with a piercing tip, the body of the piercing member having a first end and a second end positioned opposite the first end of the body, the piercing member engaging the valve sleeve.

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